Evaluation of Preoperative N1539 in Total Knee Arthroplasty

Inclusion Criteria:

- Voluntarily provide written informed consent.

- Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral
total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an
inpatient setting for ≥24 hours, and receive at least two doses of study drug.

- ASA physical status category 1, 2, or 3.

- Female subjects not pregnant or planning/attempting to become pregnant, not lactating;
or commits to the use of an acceptable form of birth control for the duration of the
study.

- Have a body mass index <40 kg/m^2

Exclusion Criteria:

- Have a known allergy or hypersensitivity to any study treatment.

- Have a history of previous TKA.

- Has plans for a concurrent surgical procedure (eg, bilateral TKA).

- Has TKA planned to be performed under general anesthesia.

- Have a history of myocardial infarction within the preceding 12 months.

- Have, as determined by the investigator or the sponsor's medical monitor, a history or
clinical manifestations of significant condition that would preclude participation.

- Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

- Have a known bleeding disorder which may be worsened with the administration of an
NSAID.

- Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within
48 hours prior to surgery.

- Have previously received N1539/IV meloxicam or received any investigational product
within 30 days before dosing with study medication.

- Have undergone or be expected to undergo radiation therapy, chemotherapy, or other
biological therapy for cancer treatment, within 60 days prior to screening through
last follow-up.